Prospecto: information for the user

Metamizol Normon 500mg/mloral drops in solution EFG

Metamizol sodium monohydrate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Metamizol Normonbelongs to the group of medications called “Otheranalgesics and antipyretics”.

This medication is used for the treatment of moderate to severe acute postoperative or post-traumatic pain, of colic type or of tumor origin. It is also used in cases of high fever that does not respond to other measures or other fever medications.

Metamizol Normon is presented in a 20 ml bottle (provided with a dropper) intended for children up to 10 years of age (or up to 30 kg of weight).

Do not use Metamizol Normon

• If you have had a significant decrease in a type of white blood cells called granulocytes, which was caused by metamizol or other similar medications called pyrazolones or pyrazolidines.
• If you have problems with your bone marrow or have a disorder that affects the way your blood cells are produced or function.
• If you have had previous allergic reactions or hematologic reactions (decrease in white blood cells, red blood cells, or platelets in the blood) with medications containing metamizol or other similar compounds or allergic reactions to any of the other components of this medication (listed in section 6).
• If you have had symptoms of asthma, rhinitis, or urticaria (red patches or hives on the skin that can cause itching) during treatment with other analgesics such as acetylsalicylic acid, paracetamol, or nonsteroidal anti-inflammatory drugs, as in these cases there may also be sensitivity to metamizol (active substance of Metamizol Normon).
• If you have intermittent acute porphyria (a disorder of the metabolism of blood pigments that form part of hemoglobin).
• If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.
• If you have had alterations in the function of the bone marrow (producer of blood cells); for example, during or after receiving antitumor chemotherapy or if you have diseases related to the formation of blood cells.
• If you are in the last three months of pregnancy.
• If you have had severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) with the use of Metamizol Normon or another medication containing metamizol.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Metamizol Normon.

Low white blood cell count (agranulocytosis).

Metamizol Normon may cause agranulocytosis, a very low level of a type of white blood cells called granulocytes, which are important for fighting infections (see section 4). You should stop taking metamizol and contact a doctor immediately if you experience the following symptoms, as they may indicate a possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (moist surfaces of the body) especially in the mouth, nose, and throat or in the genital or anal area. Your doctor will perform laboratory tests to check your blood cell count.

If you take metamizol for fever, some symptoms of agranulocytosis may be overlooked. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Metamizol Normon and even shortly after stopping metamizol.

You may develop agranulocytosis even if you have used metamizol without problems in the past.

Be especially careful:

• If you experience general discomfort, infection, persistent fever, sore throat, inflammation in the mouth, nose, or throat, lesions in the mucous membranes of the mouth or genitals, bruises, bleeding, or paleness, discontinue treatment and consult your doctor immediately. These disorders may be due to a decrease in the number of white blood cells in the blood (agranulocytosis), platelets (thrombocytopenia), or a failure in the production of all blood cells (aplastic anemia).

• If you experience dizziness, difficulty breathing, rhinitis, facial swelling, decreased blood pressure, sudden red patches on the skin, discontinue treatment and consult your doctor. These symptoms may be due to a severe allergic reaction called anaphylactic shock. This reaction is more likely if you have asthma or allergic disorders (atopy).

• If you have bronchial asthma (especially in the presence of nasal mucosa inflammation and nasal polyps), chronic urticaria, or if you are intolerant to dyes and/or preservatives or to alcohol, as the risk of possible severe allergic reactions is higher.

• If you have low blood pressure or hypovolemia (decrease in circulating blood volume or any other body fluid), dehydration, or unstable circulation, as the risk of a sudden drop in blood pressure is higher.
• If a skin rash appears that progresses to the formation of blisters or lesions in the mucous membranes, discontinue treatment and seek medical attention, as this may be due to the appearance of severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In these cases, you should not receive metamizol-containing medications again (see section 4).
• If you have decreased liver or kidney function, as you may eliminate the medication with greater difficulty.
• If you are an elderly patient, be especially attentive to the appearance of any of the disorders described above, as they may appear more frequently.

• Liver problems: Inflammation of the liver has been reported in patients taking metamizol with symptoms that develop within a few days to several months after starting treatment.

Stop using Metamizol Normon and contact a doctor if you experience symptoms of liver problems, such as nausea, vomiting, fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowing of the skin or white part of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You should not take Metamizol Normon if you have previously taken a medication containing metamizol and had liver problems.

• Severe skin reactions: Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with metamizol treatment. Stop taking metamizol and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

If you have ever had severe skin reactions, you should not restart treatment with Metamizol Normon at any time (see section 4).

Taking Metamizol Normon with food and drinks

Along with alcohol, both its effects and those of the drug may be potentiated.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The available data on the use of metamizol during the first three months of pregnancy are limited, but do not indicate harmful effects on the embryo. In selected cases where there are no other treatment options, single doses of metamizol during the first and second trimesters may be acceptable after consulting with your doctor or pharmacist and then carefully evaluating the benefits and risks of using metamizol. However, in general, it is not recommended to use metamizol during the first and second trimesters.

During the last trimester of pregnancy, you should not take Metamizol Normon due to the increased risk of complications for the mother and baby (bleeding, premature closure of a major blood vessel for the fetus, called the ductus arteriosus, which closes naturally after birth).

Lactation

The degradation products of metamizol are excreted in breast milk in significant amounts and it cannot be ruled out that there is a risk to the infant. Therefore, repeated use of metamizol during lactation should be avoided. In the event of a single dose of metamizol, mothers are recommended to express and discard breast milk for 48 hours after its administration.

Driving and operating machines

Although no adverse effects on concentration and reaction time are expected, at higher doses within the recommended range, you should be aware that these abilities may be affected and you should avoid operating machines, driving vehicles, or other hazardous activities.

Other medications and Metamizol Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If administered concurrently with ciclosporin (a medication that prevents transplant rejection), it may reduce ciclosporin levels in the blood and therefore these should be measured regularly.

If administered concurrently with chlorpromazine (a medication for the treatment of psychosis), it may cause a decrease in body temperature.

If administered concurrently with methotrexate or other antineoplastic medications, it may potentiate the toxic effects in the blood of antineoplastic medications, especially in elderly patients.

If administered concurrently with acetylsalicylic acid, it may reduce the effect of acetylsalicylic acid to decrease platelet aggregation (antiplaquetary) and therefore should be used with caution in patients taking it for heart protection (cardioprotector).

If administered concurrently with bupropion, it may reduce bupropion levels in the blood, and therefore should be used with caution. Bupropion is a medication used for the treatment of depression and/or to help quit smoking.

Metamizol may modify the effect of antihypertensive medications (medications that reduce blood pressure) and diuretics (medications that increase the elimination of liquids).

If administered concurrently with efavirenz, a medication used for the treatment of HIV/AIDS.

If administered concurrently with methadone, a medication used to treat opioid dependence.

If administered concurrently with valproate, a medication used to treat epilepsy or bipolar disorder.

If administered concurrently with tacrolimus, a medication used to prevent organ rejection in transplant patients.

If administered concurrently with sertraline, a medication used to treat depression.

Important information about some of the components of Metamizol Normon:

This medication contains 35 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 1.8% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose is established according to the intensity of the pain or fever and the sensitivity of each person to treatment with metamizol. Always select the lowest necessary dose to control pain and fever. Your doctor will tell you how to take metamizol.

The following table shows the recommended single doses and maximum daily doses according to weight or age:

Single doses can be administered up to four times a day, depending on the maximum daily dose.

The effect of the medication usually appears between 30 and 60 minutes after oral administration.

Use in children

For pain treatment, children up to 10 years old (30 kg of body weight) can take 8 to 16 mg of metamizol per kilogram of body weight in a single dose (see previous table). For fever, a dose of 10 mg of metamizol per kilogram of body weight is generally sufficient in children:

Older adults and patients with poor general health/renal insufficiency

The dose should be reduced in older adults, debilitated patients, and those with decreased renal function, as the elimination of metamizol degradation products may be delayed.

Patients with renal or hepatic insufficiency

Since in cases of renal or hepatic insufficiency the elimination rate decreases, high repeated doses should be avoided. Only in short-term treatments, a dose reduction is not necessary. There is no experience with prolonged treatments.

Administration form

The oral solution should be dosed with the dropper included in the package, which allows dosing in drops (1 drop = 25 mg metamizol sodium monohydrate).

Instructions for correct administration of the preparation:

The drops will be administered orally with a little water.

1. To extract the safety cap from the bottle, press on the surface of the same (A) and at the same time unscrew in the opposite direction to the clock hands (B).

1. Once the cap is extracted, place the bottle in a vertical position and completely inverted. DO NOT SHAKE. WAIT A FEW SECONDS UNTIL THE FIRST DROP APPEARS.

1. Close the bottle well after each administration.

Warnings for correct dosing:

• Do not extract the content with a syringe.

There is a risk of permanently damaging the dropper and it will not be possible to use it afterwards.

• Do not use a syringe for your dosing in drops.

Duration of administration

The duration of treatment will be established according to the type and severity of the disease and will be decided by your doctor.

It is recommended not to take analgesics for more than 3 to 5 days without consulting your doctor or dentist again.

If you take more Metamizol Normon than you should

Nausea, vomiting, abdominal pain, renal function deterioration, and in very rare cases, dizziness, somnolence, coma, convulsions, and decreased blood pressure may appear.

After administration of very high doses of metamizol, a reddish discoloration of the urine may occur, which disappears when treatment is suspended.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20.

If you forgot to take Metamizol Normon

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Mild allergic reactions (such as skin and mucous membrane reactions like itching, burning, redness, swelling) as well as difficulty breathing and gastrointestinal discomfort may progress to more severe forms, such as generalized urticaria, swelling of the feet, hands, lips, throat, and respiratory passages (angioedema), severe bronchospasm (narrowing of the bronchial walls), heart rhythm disturbances, and decreased blood pressure (sometimes preceded by an increase in blood pressure).

Stop using Metamizol Normon and contact a doctor immediately if you experience any of the following symptoms:

Feeling of illness (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, light-colored stools, yellow discoloration of the skin or the white part of the eyes, itching, rash, or pain in the upper stomach area. These symptoms may be signs of liver damage. See also section 2 Warnings and precautions.

Other side effects that may occur with the following frequencies are:

Frequent (may affect up to 1 in 10 people):

• Low blood pressure.

Infrequent (may affect up to 1 in 100 people):

• Rashes and skin reactions.

Rare (may affect up to 1 in 1,000 people):

• Allergic reactions that usually occur during or shortly after administration but also hours later,

• Rashes and appearance of blisters on the skin,

• Decreased white blood cell count in the blood (leucopenia),
• Asthma.

Very rare (may affect up to 1 in 10,000 people):

• Skin reactions with the appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• Renal problems with decreased or suppressed urine output,
• Increased protein excretion in the urine,
• Interstitial nephritis (inflammation of the kidneys),
• Severe decrease in white blood cells (agranulocytosis) that may cause death due to severe infections,
• Decreased platelet count in the blood (thrombocytopenia), in this case, may cause inflammatory lesions in mucous membranes, throat pain, and fever,
• Shock (drastic drop in blood pressure).

Frequency unknown (cannot be estimated from available data):

• Sepsis (severe infection that involves a systemic inflammatory reaction and may cause death),
• Aplastic anemia (failure in the production of bone marrow and blood cells),
• Pancytopenia (low count of red and white blood cells and platelets simultaneously),
• Anaphylactic shock (severe allergic reaction that may cause death),
• Kounis syndrome (a type of cardiac disorder),
• Gastrointestinal bleeding,
• Cyanosis (abnormal discoloration of the urine),
• Liver inflammation, yellow discoloration of the skin and the white part of the eyes, increased blood levels of liver enzymes.
• Severe skin reactions: stop taking metamizol and seek medical attention immediately if you observe any of the following severe side effects:

- flat, red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

- generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the bottle after “CAD”. The expiration date is the last day of the month indicated.

After the first opening of the bottle, the validity period of the medication is 12 months.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Metamizol Normon

The active ingredient is metamizol sodium monohydrate. 1 ml (20 drops) of solution contains 500mg of metamizol sodium monohydrate (1 drop contains 25mg of metamizol sodium monohydrate).

The other components are:

Sodium dihydrogen phosphate, sodium monohydrogen phosphate, raspberry essence, sodium saccharin, purified water.

Appearance of the product and contents of the packaging

Clear, colorless to pale yellow solution.

It is presented in an amber glass bottle of 20 ml with a child-resistant screw cap, packaged in a cardboard box. The bottle has an incorporated dropper as a device for administration

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:November 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/83494/P_83494.html